HMD · Chair, Ophthalmic, Manual
Ophthalmic · 21 CFR 886.1140 · Class 1
Overview
| Product Code | HMD |
|---|---|
| Device Name | Chair, Ophthalmic, Manual |
| Regulation | 21 CFR 886.1140 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
An ophthalmic chair is an AC-powered or manual device with adjustable positioning in which a patient is to sit or recline during ophthalmological examination or treatment.
Classification Rationale
Class I. The AC-powered device and the manual device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The manual device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K833538 | DOWING OPHTHALMIC CHAIR-NON/AC POWER | Vision Health Technology | Mar 5, 1984 | SESE |
Top Applicants
- Vision Health Technology — 1 clearance
